Effects of Phototherapy on Diabetes Mellitus and Control of Cardiac Functio

Not Applicable

• Conditions: on-insulin-dependent diabetes mellitus; E00-E90

• Registration Number: RBR-38wn44
• Lead Sponsor: niversidade do Sagrado Coração

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-21
• Study Completion: 2020-12-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Volunteers of both genders were recruited; aged between 40 and 80 years; body mass index (BMI) between 20 and 39.9 km/m2, ie, eutrophic; pre-obese or moderately obese subjects (grade I); and obese (grade II). Volunteers should be clinically diagnosed as diabetic (fasting glycemia less than or equal to 126 mg / dL); and be sedentary or irregularly active according to the short version of the IPAQ.

Exclusion Criteria

Volunteers who presented cancer were excluded; or history of cancer in the region of the lower and upper limbs; infection; neurological deficits; have coagulation disorders; as well as insulin-dependent volunteers.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: reduced blood glucose of at least 10 mg/dl (measured by monitoring capillary blood glucose) after treatment with phototherapy dose of 100 Joules or 240 Joules;Outcome found 1: reduced blood glucose of at least 10 mg/dl (measured by capillary blood glucose monitoring) after treatment with phototherapy (isolated) using dose of 100 Joules compared to placebo group (0 Joules).

Secondary Outcome Measures

Name	Time	Method
Expected outcome 2: changes in heart rate variability (at least 3 units) after treatment with phototherapy doses of 100 Joules or 240 Joules combined or not with hypoglycemic drug (routinely used by the patients)<br><br>;Outcome found 2: increase of at least 5 units (un) in the low-frequency component of heart rate variability for placebo treatment (0 J) combined with hypoglycemic drug (routinely used by the patients), and increase of at least 10 units in the low-frequency component for treatment with phototherapy (isolated) with dose of 100 J.